NCT01115244|TerminatedPhase 4ResultsDMCFDA Drug
Loading search results
poor enrollment and lack of funding
Dapsone Gel, 5% for Topical Treatment of Dermatitis Herpetiformis
Sponsor study identifier
interventional
1
1 country
1
Study Start
July 2010
Actual (reported)Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)The primary objective of this study is to evaluate the efficacy of dapsone gel, 5% in the treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion of patients achieving success based on mean % reduction from baseline in total lesion counts at week six. Success for lesion reduction will be defined as statistically greater mean percent reductions at week six in the dapsone gel-treated extremity compared with the control extremity of each patient.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 23, 2010
Actual (reported)May 4, 2010
Actual (reported)July 2010
Actual (reported)March 2012
Actual (reported)March 2012
Actual (reported)December 14, 2017
Actual (reported)Number and Size of All Lesions on the Treated and Untreated Elbows or Knees of Patients With Dermatitis Herpetiformis Who Have One Extremity Treated With Dapsone Gel, 5%
The primary objective is to evaluate the efficacy of dapsone gel, 5% in the treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion of patients achieving success based on mean % reduction from baseline in total lesion counts at week six. Digital photographs of each elbow or each knee (treatment and control) will be taken. The number and size of lesions will be recorded for the treatment and control elbow or knee. This process will be repeated at each follow up visit.
6 weeks of treatment
Number of Papules, Plaques and Vesicles on Treated and Untreated Elbows or Knees of Patients Who Have One Extremity Treated With Dapsone Gel, 5%
6 weeks of treatment
Evaluation of Clinical Photographs and Scoring of Photographs Based on a Modified Global Acne Assessment Score
6 weeks of treatment
ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.
One arm of the patient will be left untreated.
ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.
Vanderbilt University - One Hundred Oaks
Nashville, Tennessee, 37204, United States
1 participants (actual enrollment reported by the registry).
First Submitted
April 23, 2010
First Posted
May 4, 2010
Study Start
July 2010
Actual (reported)Primary Completion
Aczone Gel 7.5% in the Treatment of Acne Vulgaris in Patients With Skin of Color
Contact the study team to confirm eligibility.
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
December 14, 2017
Results First Posted
December 14, 2017
Record last verified: 2017-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: